BEUDAMED
    FDA Adverse Event Other Summary report: N

    QUILL SRS

    MDR report key: 1246386 · Received November 26, 2008

    Report

    Report Number
    2522801-2008-00042
    Event Type
    Other
    Date Received
    November 26, 2008
    Date of Event
    October 1, 2008
    Report Date
    November 26, 2008
    Manufacturer
    SURGICAL SPECIALTIES CORP. (DBA ANGIOTECH)
    Product Code
    GAB
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DATE OF THE EVENT IS ESTIMATED. A MODEL NUMBER AND LOT NUMBER WERE NOT PROVIDED. A DEVICE WAS NOT RETURNED FOR EVALUATION. FURTHERMORE, THE MODEL NUMBER(S) / LOT NUMBER(S) ARE UNKNOWN. RESULTS: A DEVICE WAS NOT RETURNED FOR EVALUATION. NO PRODUCT EVALUATION CAN BE PERFORMED.

    Description of Event or Problem · 1

    MULTIPLE PATIENTS UNDERWENT TOTAL KNEE PROCEDURES USING QUILL SRS FOR CLOSURE OF SUPERFICIAL LAYER. IT WAS REPORTED THAT THE HEALING PROCESS WAS DELAYED, AND SEVERE SKIN NECROSIS OCCURRED, WHICH REQUIRED MULTIPLE SURGICAL DEBRIDEMENTS. NUMEROUS ATTEMPTS TO OBTAIN CASE SPECIFIC INFORMATION REGARDING THE EVENTS WERE UNSUCCESSFUL. THE NUMBER OF EVENTS, PATIENT INFORMATION, PRODUCT INFORMATION (EXCEPT MATERIAL TYPE), ETC. ARE ALL UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 QUILL SRS BARBED SUTURE WITH NEEDLE GAB SURGICAL SPECIALTIES CORP. (DBA ANGIOTECH) UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention NONE MADE AVAILABLE